Simcyp Consultancy Services

Consultancy and guidance on a broad spectrum of DMPK issues, including optimal design for metabolic drug-drug interaction studies, interpretation of data and prediction of in vivo ADME from in vitro studies.

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FDA-Pharsight CRADA

Certara has had a long history of collaboration with the Food and Drug Administration (FDA) on new technologies to support the drug development process. Currently, the FDA uses a wide range of Certara software products including our desktop platform, Phoenix. The Phoenix platform is used by the FDA, along with software products from other suppliers, to review clinical trial data, especially for clinical pharmacology and clinical safety reviews.

Pharsight, now part of Certara, had a Cooperative Research and Development Agreement (CRADA) with the FDA Center for Drug Evaluation and Research (CDER) from 2001 to 2013. The Pharsight CRADA directly supported the FDA’s Critical Path Initiative, which advocates increased use of drug-disease modeling and simulation to improve the efficiency of the drug product development process.

Since many drug sponsors use Phoenix software in their submissions, it is essential for the FDA to also have this software to complete IND and NDA drug reviews. Certara continues to provide FDA with technical support and on-site training in the use of our products.